U.S. patent number 9,924,930 [Application Number 14/616,674] was granted by the patent office on 2018-03-27 for vascular hole closure device.
This patent grant is currently assigned to Rex Medical, L.P.. The grantee listed for this patent is Rex Medical, L.P.. Invention is credited to Thanu Anidharan, John D. Leedle, James F. McGuckin, Jr., James S. Tarmin.
United States Patent |
9,924,930 |
McGuckin, Jr. , et
al. |
March 27, 2018 |
Vascular hole closure device
Abstract
A device for closing an aperture in a vessel wall comprising a
covering member having a longitudinal axis and positionable inside
the vessel against the internal opening of the aperture and a first
spherical retainer positionable external of the vessel. The
covering member has a dimension to prevent egress of fluid through
the aperture.
Inventors: |
McGuckin, Jr.; James F.
(Radnor, PA), Leedle; John D. (Philadelphia, PA), Tarmin;
James S. (Philadelphia, PA), Anidharan; Thanu
(Downingtown, PA) |
Applicant: |
Name |
City |
State |
Country |
Type |
Rex Medical, L.P. |
Conshohocken |
PA |
US |
|
|
Assignee: |
Rex Medical, L.P.
(Conshohocken, PA)
|
Family
ID: |
40955809 |
Appl.
No.: |
14/616,674 |
Filed: |
February 7, 2015 |
Prior Publication Data
|
|
|
|
Document
Identifier |
Publication Date |
|
US 20150150548 A1 |
Jun 4, 2015 |
|
Related U.S. Patent Documents
|
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|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
13290941 |
Nov 7, 2011 |
8968361 |
|
|
|
12358411 |
Dec 6, 2011 |
8070772 |
|
|
|
61066072 |
Feb 15, 2008 |
|
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B
17/0057 (20130101); A61B 2017/00615 (20130101); A61B
2017/00659 (20130101); A61B 2017/00004 (20130101); A61B
2017/00623 (20130101) |
Current International
Class: |
A61B
17/00 (20060101) |
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Other References
European Search Report Application No. 10175821.7 dated Mar. 17,
2017. cited by applicant.
|
Primary Examiner: Dornbusch; Dianne
Attorney, Agent or Firm: Gershon; Neil D.
Parent Case Text
BACKGROUND
This application is a continuation of U.S. application Ser. No.
13/290,941, filed Nov. 7, 2011, which is a division of U.S
application Ser. No. 12/358,411, filed Jan. 23, 2009, now U.S. Pat.
No. 8,070,772, which claims priority from provisional application
Ser. No. 61/066,072, filed Feb. 15, 2008, the entire contents of
which is incorporated herein by reference.
Claims
What is claimed is:
1. A device for closing an aperture in a wall of a vessel, the
aperture extending through the wall of the vessel and communicating
with an internal lumen of the vessel, the device comprising: a
distal covering member positionable within the vessel against the
aperture, the covering member having a dimension to prevent blood
flow through the aperture; a first retainer positionable external
of the vessel and proximal of the covering member the retainer
retaining the covering member inside the vessel to prevent blood
flow from the lumen of the vessel through the aperture; a first
connecting member having a first portion and a second portion,
wherein the first retainer is fixedly attached to the first
connecting member at the first portion of the first connecting
member, wherein applying a proximally directed force on the second
portion of the first connecting member advances the first retainer
distally toward the covering member; a second retainer; and a
second connecting member having a first portion and a second
portion, wherein the second retainer is fixedly attached to the
second connecting member at the first portion of the second
connecting member, wherein applying a proximally directed force on
the second portion of the second connecting member advances the
second retainer distally toward the covering member.
2. The device of claim 1, wherein the second retainer is
positionable external of the vessel and movable distally toward the
covering member.
3. The device of claim 1, wherein the covering member is composed
of a resorbable material.
4. The device of claim 3, wherein the first and second retainers
and the first and second connecting members are composed of a
resorbable material.
5. The device of claim 1, wherein the covering member is elongated
in configuration and is retained in a delivery sheath in a
longitudinal position for delivery and transitions to a transverse
placement position within the vessel.
6. The device of claim 1, wherein the first and second retainers
are positioned in a stacked relationship in a delivery
position.
7. The device of claim 6, wherein the first and second retainers in
a placement position are positioned in a substantially side by side
relationship.
8. The device of claim 1, wherein the first and second retainers in
a placement position are positioned in a substantially side by side
relationship.
9. The device of claim 1, wherein the covering member has a thicker
region in a central region than in end regions.
10. The device of claim 1, wherein the covering member has a
transverse dimension less than a longitudinal dimension.
11. A device for closing an aperture in a wall of a vessel, the
aperture extending through the wall of the vessel and communicating
with an internal lumen of the vessel, the device comprising: an
intravascular covering member having a dimension to prevent blood
flow through the aperture, the covering member having first and
second openings; a first extravascular retainer positionable
proximal of the covering member, the first extravascular retainer
retaining the intravascular covering member within the vessel; a
first connecting member having a first portion and a second
portion, the first connecting member looping through the first and
second openings of the covering member, the first retainer fixedly
attached to the first connecting member such that movement of the
first connecting member moves the attached first extravascular
retainer, wherein pulling a portion of the first connecting member
in a direction away from the covering member advances the first
retainer in an opposite direction toward the covering member; a
second extravascular retainer positionable proximal of the covering
member and movable toward the covering member; and a second
connecting member having a first portion and a second portion, the
second connecting member looping through third and fourth openings
of the covering member, the second retainer fixedly attached to the
second connecting member such that movement of the second
connecting member moves the attached second extravascular retainer,
wherein pulling a portion of the second connecting member in a
direction away from the covering member advances the second
retainer in an opposite direction toward the covering member.
12. The device of claim 11, wherein the first and second
extravascular retainers and the first and second connecting members
are composed of resorbable material.
13. The device of claim 12, wherein the covering member is composed
of resorbable material.
14. The device of claim 11, wherein the first and second
extravascular retainers are positioned in side by side relationship
in a placement position.
15. The device of claim 14, wherein the first and second retainers
are positioned in a stacked relationship in a delivery position.
Description
TECHNICAL FIELD
This application relates to a vascular device and more particularly
to a device for closing openings in vessel walls.
BACKGROUND OF RELATED ART
During certain types of vascular surgery, catheters are inserted
through an incision in the skin and underlying tissue to access the
femoral artery in the patient's leg. The catheter is then inserted
through the access opening made in the wall of the femoral artery
and guided through the artery to the desired site to perform
surgical procedures such as angioplasty or plaque removal. After
the surgical procedure is completed and the catheter is removed
from the patient, the access hole must be closed. This is quite
difficult not only because of the high blood flow from the artery,
but also because there are many layers of tissue that must be
penetrated to reach the femoral artery.
Several approaches to date have been used to close femoral access
holes. In one approach, manual compression by hand over the
puncture site is augmented by a sandbag or weight until the blood
coagulates. With this approach, it can take up to six hours for the
vessel hole to close and for the patient to be able to ambulate.
This inefficiency increases the surgical procedure time as well as
the overall cost of the procedure since the hospital staff must
physically maintain pressure and the patient's discharge is delayed
because of the inability to ambulate.
In another approach to close the vessel puncture site, a clamp is
attached to the operating table and the patient's leg. The clamp
applies pressure to the vessel opening. The patient, however, must
still be monitored to ensure the blood is coagulating, requiring
additional time of the hospital staff and increasing the cost of
the procedure.
To avoid the foregoing disadvantages of manual pressure approaches,
suturing devices have been developed. One such suturing device,
referred to as "the Closer" and sold by Perclose, advances needles
adjacent the vessel wall opening and pulls suture material
outwardly through the wall adjacent the opening. The surgeon then
ties a knot in the suture, closing the opening. One difficulty with
the procedure involves the number of steps required by the surgeon
to deploy the needles, capture the suture, withdraw the suture, and
tie the knot and secure the suture. Moreover, the surgeon cannot
easily visualize the suture because of the depth of the femoral
artery (relative to the skin) and essentially ties the suture knot
blindly or blindly slips a pre-tied knot into position.
Additionally, the ability to tie the knot varies among surgeons;
therefore success and accuracy of the hole closure can be dependent
on the skill of the surgeon. Yet another disadvantage of this
suturing instrument is that the vessel opening is widened for
insertion of the instrument, thus creating a bigger opening to
close in the case of failure to deliver the closure system. It is
also difficult to pass the needle through calcified vessels.
U.S. Pat. No. 4,744,364 discloses another approach for sealing a
vessel puncture in the form of a device having an expandable
closure member with a filament for pulling it against the vessel
wall. The closure member is held in place by a strip of tape placed
on the skin to hold the filament in place. However, the closure
device is still subject to movement which can cause leakage through
the puncture. Additionally, if the suture becomes loose, the
closure member is not retained and can flow downstream in the
vessel. Moreover, since the suture extends through the skin, a
potential pathway for infection is created. The closure device in
U.S. Pat. No. 5,545,178 includes a resorbable collagen foam plug
located within the puncture tract. However, since coagulation
typically takes up to twenty minutes and blood can leak in between
the plug and tissue tract, manual pressure must be applied to the
puncture for a period of time, until the collagen plug expands
within the tract.
It would therefore be advantageous to provide a device which would
more quickly and effectively close openings (punctures) in vessel
walls. Such device would advantageously avoid the aforementioned
time and expense of applying manual pressure to the opening,
simplify the steps required to close the opening, avoid widening of
the opening, and more effectively retain the closure device in the
vessel.
Commonly assigned co-pending patent U.S. application Ser. No.
10/847,141, filed May 17, 2004, discloses effective vascular hole
closure devices which have the foregoing advantages. It would be
further advantageous to provide a vascular hole closure device
which is adjustable to accommodate different tissue thicknesses and
applies a more constant clamping/retaining force between the
intravascular and extravascular components of the device
irrespective of tissue thickness.
SUMMARY
The present invention overcomes the disadvantages and deficiencies
of the prior art. The present invention provides a device for
closing an aperture in a vessel wall, the aperture having an
external opening in an external region of the vessel wall and an
internal opening in an internal region of the vessel wall. The
device comprises a covering member having a longitudinal axis and
positionable inside the vessel against the internal opening of the
aperture and a first spherical retainer positionable external of
the vessel. The covering member has a dimension to prevent egress
of fluid through the aperture.
The device preferably includes a second spherical member and first
and second sutures attached to respective spherical members.
Preferably, pulling of the first suture moves the first retainer
toward the covering member and pulling of the second suture moves
the second retainer toward the covering member.
Preferably the covering member is composed of a resorbable
material. In a preferred embodiment, the retainers and sutures are
also composed of a resorbable material.
In a preferred embodiment, the retainers in a placement position
are positioned in a substantially side by side relationship and in
the delivery position are positioned in stacked relationship.
The present invention also provides a method of closing an aperture
in a vessel wall, the aperture having an external opening in an
external region of the vessel wall and an internal opening in an
internal region of the vessel wall. The method comprises inserting
a covering member inside the vessel against the internal opening of
the aperture, the covering member having a dimension to prevent
egress of fluid through the aperture, inserting a first spherical
retainer external of the vessel, and advancing the first retainer
toward the covering member.
Preferably, the step of advancing the first retainer comprises the
step of moving a suture, wherein the first retainer is fixedly
attached to the suture. The method also preferably includes the
step of inserting a second spherical retainer external of the
vessel and advancing the second retainer toward the covering member
by suture movement. Preferably, the first and second retainers are
placed in side by side relationship and left in the body to resorb
over a period of time.
BRIEF DESCRIPTION OF THE DRAWINGS
Preferred embodiment(s) of the present disclosure are described
herein with reference to the drawings wherein:
FIG. 1 is a perspective view of a first embodiment of the closure
device of the present invention;
FIG. 2 is a side perspective view of the covering member of the
closure device of FIG. 1 shown within the delivery sheath;
FIG. 3 is a side perspective view illustrating the covering member
of FIG. 2 deployed from the delivery sheath;
FIG. 4 is a side view illustrating one of the spherical retainers
of the closure device deployed from the sheath (the vessel wall
shown in cross-section);
FIG. 5 illustrates both spherical retainers deployed from the
sheath;
FIG. 6 illustrates the sutures pulled to move the spherical
retainers toward the covering member for positioning in a side by
side relationship against the outer surface of the vessel wall;
FIG. 7 is a perspective view illustrating the retainers in the
placement position;
FIG. 8 is a perspective view of the covering member and sutures of
an alternate embodiment of the closure device of the present
invention showing the sutures attached to the covering member via a
looped suture; and
FIG. 9 is a perspective view illustrating an alternate orientation
of the retainers in the placement position.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
Referring now in detail to the drawings where like reference
numerals identify similar or like components throughout the several
views, FIG. 1 is a perspective view of a first embodiment of the
vascular hole (aperture) closure device of the present invention.
The device is intended to close an aperture in the vessel wall,
typically formed after removal of a catheter previously inserted
through the vessel wall into the vessel lumen for performing
angioplasty or other interventional procedures. The aperture
extends through the patient's skin and underlying tissue, through
the external wall of the vessel, through the wall of the vessel,
and through the internal wall of the vessel to communicate with the
internal lumen of the vessel. The closure device of the present
invention has an intravascular component to block blood flow and an
extravascular component to retain the intravascular component.
More specifically, the closure device includes a covering member or
patch positioned within the vessel against the internal wall of the
vessel to block blood flow and two spherical retainers positioned
external of the vessel wall to retain the covering member in its
blocking position. Each retainer is fixedly attached to a suture
such that pulling of the suture advances the attached retainer
toward the covering member to ultimately position the retainers in
a side by side relationship either against or adjacent the external
surface of the vessel wall.
Turning to FIGS. 1-7, a first embodiment of the closure device of
the present invention is illustrated. Hole (aperture) closure
device 10 has a covering member or patch 40 and a first spherical
retainer or ball 20 and a second spherical retainer or ball 22. The
covering member 40 is dimensioned and configured for positioning
inside the vessel on the internal side of the vessel aperture
against the internal wall of the vessel; the retainers 20, 22 are
configured to be positioned outside the vessel wall adjacent or
contiguous the external side of the vessel aperture.
Covering member 40, preferably elongated in configuration as shown,
is retained in a delivery sheath in a longitudinal position for
delivery to the vessel, and then pivots to a transverse position
within the vessel lumen (substantially perpendicular to an axis
extending through the aperture), for orientation to cover (patch)
the vessel aperture on the internal side. This movement is
illustrated in FIGS. 37A-37D of commonly assigned co-pending patent
U.S. application Ser. No. 10/847,141, filed May 17, 2004, the
entire contents of which are incorporated herein by reference
(hereinafter the '141 application).
The spherical retainers are preferably held in the delivery tube in
a stacked relationship (not shown), with retainer 22 atop retainer
20 (or vice versa).
The elongated covering member 40 functions to cover (patch) the
internal opening in the vessel wall to prevent the egress of blood.
With reference to FIGS. 1 and 4, the covering member 40 is
preferably somewhat oval shaped with elongated substantially
parallel side walls 42a, 42b and end walls 44a, 44b connecting the
side walls 42a, 42b. Other shapes of the covering member are also
contemplated. Although the ends preferably have substantially
straight wall portions 44a, 44b, curved walls are also
contemplated. Covering member preferably has a thicker region 43 in
the central region than the first and second end regions 45, 47.
Other dimensions are also contemplated.
The longitudinal axis of covering member 40 defines a lengthwise
dimension and transverse axes define a shorter widthwise
dimensions. The widthwise dimension of the covering member 40 can
be about 2.5 mm (for a 6 Fr device). In a preferred embodiment, the
covering member 40 is about 3.3 mm in widthwise dimension. Other
dimensions are also contemplated. The width preferably is at least
substantially equal to the dimension of the internal opening in the
vessel wall to effectively cover the opening. In a preferred
embodiment, the covering member 40 has a length of about 8 mm (in a
6 French system).
It should be appreciated that alternatively the covering member
could be provided with an enlarged width region as illustrated in
the embodiment of FIG. 1 of the '141 application.
The covering member could also be configured asymmetrically so that
the enlarged region is off-centered to accommodate widening of the
aperture as the member is pulled at an angle. The covering member
could also be configured in a paddle shaped with a narrowed region
adjacent a wider region as in FIGS. 9B-9E of the '141 application.
Other covering member configurations including those disclosed in
the '141 application could be utilized with the retainers of this
present application.
The elongated covering member can be composed of materials such as
polycarbonate or polyurethane. Preferably it is composed of
resorbable materials such as lactide/glycolide copolymers that
after a period of time resorb in the body. If composed of
resorbable material, the covering member could optionally have
regions of varying resorbability. Varying degrees of resorbability
can be achieved for example by utilizing different materials having
differing resorbable characteristics or by varying the mass of the
covering member (increased mass increases resorbtion time).
Spherical retainers 20 and 22 are preferably composed of resorbable
material. In a preferred embodiment, the diameter of each retainer
20, 22 is about 0.095 inches, although other dimensions are
contemplated. Although shown as spheres, other rounded shapes are
also contemplated. The retainers could alternatively be made of
non-absorbable polymeric or metallic material.
When the retainers 20 and 22 are released from the delivery
instrument, they are spaced further from the covering member 40.
They are then configured to be advanced toward the covering member
40. More specifically, each retainer 20, 22 is fixedly secured to a
respective suture 30, 32. Sutures 30, 32 are preferably made of
polymeric material and are preferably resorbable, composed of a
material such as polydioxanome. It is also contemplated that
alternatively a metallic material could be utilized.
As shown, suture 30 has a free end 30a and an opposite end 30b
secured to retainer 20 by molding, gluing, forming a knot, or other
methods. Similarly, suture 32 has a free end 32a and an opposite
end 32b secured to retainer 22 in a similar manner. The suture is
shown in the embodiment of FIG. 1 looped through the covering
member. Other methods of attachment are also contemplated. For
example, in the alternative embodiment of FIG. 8, sutures 150, 152
are attached to covering member 140 by a loop of suture 160. Loop
160 extends upwardly (proximally) from the covering member 140 and
the sutures 150, 152 are looped through suture loop 160.
To advance the retainers 20, 22 toward the vessel wall (and
covering member), the free end of each suture is pulled proximally
(in a direction of the arrow of FIG. 4, thereby moving the
respective retainer in the opposite direction closer to the
aperture A and vessel wall W. Once tightened against the tissue, a
sufficient retention force is maintained, i.e. a proximal pulling
force on the covering member 40 to pull it slightly upwardly
(proximally) against the vessel wall. The retainers 20, 22
therefore help to prevent the covering member 40 from separating
from the vessel wall (e.g. moving in the direction toward the
opposing vessel wall) which could create an unwanted gap between
the covering member 40 and the vessel opening to allow blood flow.
The extent to which the retainers 20, 22 move toward the wall (and
thus their distance from the vessel wall in their final placement
position) will depend on the tissue thickness. Thus, the closure
device can adjust for different tissue thicknesses and apply a
constant retention force regardless of tissue thickness.
The delivery instrument for inserting the closure device extends
through an opening in the skin, through the tissue tract to the
vessel, through an external opening in the vessel wall, through the
aperture in the vessel wall, and through an internal opening on the
internal side of the vessel wall into the vessel lumen.
The covering member 40 in FIG. 2 is outside retainer tube 50 and
within delivery sheath 60 in a tilted position. The covering member
40 emerges from the sheath 60 and moves from a tilted and
preferably a somewhat straightened positioned, (substantially
aligned with the longitudinal axis of the sheath) to a transverse
position within the vessel (see FIG. 3). (Note the vessel wall is
shown in FIG. 3 but the rest of the vessel and tissue are removed
for clarity.) The retainers 20, 22 remain within tube 50. Note the
covering member 40 can be ejected by a pusher (not shown)
contacting the side or top wall.
As shown in FIG. 4 covering member 40 is pulled proximally to abut
the internal opening on the internal side of the vessel W to cover
(patch) the opening and the suture extends through the opening A in
the vessel wall. The first retainer 20 is shown ejected from the
sheath S in FIG. 4 either by advancing the retainer, retracting the
sheath or relative movement of both. The second retainer 22 is
still within tube 50. The second retainer 22 is then deployed in a
similar manner as retainer 20 and is shown outside sheath 60 in
FIG. 5. Note that in the delivery position, the retainers 20 and 22
are preferably in a stacked relationship (not shown) to minimize
the transverse dimension of the delivery system.
Then, to retain the covering member 40 in position against the
vessel wall to block blood flow therethrough, sutures 30 and 32 are
pulled proximally from their free ends in the direction of arrows B
of FIG. 6, thereby advancing the retainers 20, 22 distally in the
direction of arrows C toward the vessel wall V and covering member
40. As shown, the retainers 20, 22 can be moved to a position
contiguous to the vessel wall, or depending on tissue thickness,
may be adjacent the wall with some tissue interposed between the
retainers and vessel wall. The retainers 20, 22 in this position
apply a proximal (upward) force on the elongated covering member 40
to limit movement of the covering member into the vessel. The
retainers in this placement position are preferably in a
substantially side by side relationship as shown in FIG. 7.
As shown in FIG. 7, in the side by side relationship, the retainers
20 and 22 are alongside in a transverse orientation with respect to
covering member 40. That is, they are positioned along the width of
the covering member 40. However it is also contemplated that the
retainers in the placement position can be in a lengthwise
orientation (substantially parallel to the longitudinal axis of the
covering member) as shown in FIG. 9 where corresponding components
to FIG. 7 have prime designations. The retainers could also be in
other side by side arrangements at angles to the longitudinal
axis.
While the above description contains many specifics, those
specifics should not be construed as limitations on the scope of
the disclosure, but merely as exemplifications of preferred
embodiments thereof. Those skilled in the art will envision many
other possible variations that are within the scope and spirit of
the disclosure as defined by the claims appended hereto.
* * * * *